UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058976 |
|---|---|
| Receipt number | R000067240 |
| Scientific Title | Cross-Sectional Study on Nutritional Status of Community-Dwelling Frail and Non-Frail Older Adults |
| Date of disclosure of the study information | 2025/09/04 |
| Last modified on | 2025/09/03 10:17:40 |
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Basic information
Public title
Cross-Sectional Study on Nutritional Status of Community-Dwelling Frail and Non-Frail Older Adults
Acronym
Cross-Sectional Study on Nutritional Status of Community-Dwelling Frail and Non-Frail Older Adults
Scientific Title
Cross-Sectional Study on Nutritional Status of Community-Dwelling Frail and Non-Frail Older Adults
Scientific Title:Acronym
Cross-Sectional Study on Nutritional Status of Community-Dwelling Frail and Non-Frail Older Adults
Region
| Japan |
Condition
Condition
Community-Dwelling Older Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the nutritional status and appetite-related hormone levels of community-dwelling frail and pre-frail older adults with those of non-frail older adults.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood concentration of nutrients and appetite-related hormones
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Frail and Pre-Frail Groups
1.Subjects aged 75 years or older
2.Subjects with a revised J-CHS Score of 1 or Higher
Non-Frail Group
1.Subjects aged 75 years or older
2.Subjects with a revised J-CHS Score of 0
Key exclusion criteria
1.Subjects with neuromuscular diseases or stroke
2.Subjects with low cognitive function (MMSE-J score 23 or less)
3.Subjects with a Revised Barthel Index score of 80 or less
4.Subjects in a medical facility or care facility
5.Subjects who are judged inappropriate for the study by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakuma |
Organization
Tokyo bay rehabilitation hospital
Division name
Medical department
Zip code
275-0026
Address
2-23-11 Yatsu, Narashino city, Chiba, 275-0026, Japan
TEL
047-453-9000
k.sakuma1992@gmail.com
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakuma |
Organization
Tokyo bay rehabilitation hospital
Division name
Medical department
Zip code
275-0026
Address
2-23-11 Yatsu, Narashino city, Chiba, 275-0026, Japan
TEL
047-453-9000
Homepage URL
k.sakuma1992@gmail.com
Sponsor or person
Institute
Tokyo bay rehabilitation hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Tokyo Bay Rehabilitation Hospital
Address
2-23-11 Yatsu, Narashino city, Chiba, 275-0026, Japan
Tel
047-453-9000
k.sakuma1992@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Research design
Observational study
2.Main Outcomes
blood concentration of nutrients and appetite-related hormones
Management information
Registered date
| 2025 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067240
